Director Medical Governance and Compliance

PepsiCo•Chicago, IL

10d

About The Position

The Medical Governance and Compliance Lead, Medical Affairs is responsible for ensuring the scientific rigor, data integrity, and regulatory compliance of all Medical Affairs activities at PepsiCo. This role establishes and oversees the quality framework that enables unbranded, science‑centric engagement, evidence generation, and external scientific collaboration in a compliant and scalable manner. The role partners closely with Medical Affairs leadership, Legal, Regulatory, Policy, and Clinical Operations to ensure PepsiCo’s medical strategy is executed with the highest standards of quality, transparency, and credibility.

Requirements

Advanced degree in life sciences, medicine, pharmacy, public health, or related field.
Demonstrated experience in Medical Affairs, clinical quality, regulatory compliance, or scientific governance.
Strong understanding of evidence generation, scientific communications, and unbranded engagement models.
Experience working in highly regulated environments with cross‑functional stakeholders.
Proven ability to balance rigor, speed, and innovation in a complex organization.

Responsibilities

Establish and maintain quality standards for Medical Affairs activities, including evidence synthesis, meta‑analyses, clinical studies, and real‑world evidence.
Ensure scientific outputs are accurate, traceable, reproducible, and supported by appropriate documentation.
Oversee quality review of scientific and educational materials used in unbranded engagement.
Ensure compliance with applicable regulatory requirements governing scientific communications and engagement.
Partner with Legal and Regulatory teams to interpret and operationalize evolving regulations.
Maintain audit‑ready documentation and inspection preparedness for Medical Affairs activities.
Govern the compliant execution of scientific engagement strategies, including KOL interactions and external collaborations.
Own Sunshine Act and transparency processes related to Medical Affairs engagements.
Ensure fair market value and ethical standards are applied consistently.
Develop and manage Medical Affairs SOPs, approval workflows, and quality controls.
Implement risk‑based quality management approaches across regions and programs.
Drive harmonization and best‑practice sharing across Medical Affairs teams.
Proactively identify quality and compliance risks and implement mitigation strategies.
Lead deviation management, root‑cause analysis, and corrective/preventive actions.
Continuously evolve quality frameworks to support new Medical Affairs capabilities and growth.